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DCTs and Devices: Lessons Learned from a Breakthrough Medical Device Trial in Women’s Health

Medical device trials are inherently challenging, particularly in women's health. But, within the context of a pandemic, the hurdles may seem insurmountable.

Men's/Women's Health
Genito Urinary
Download the PDF

Medical device trials are inherently challenging, particularly in women's health. But, within the context of a pandemic, the hurdles may seem insurmountable. Common obstacles can include:

The stigma associated with certain women’s health conditions.

The need to capture data throughout the day and night.

Participant concerns about medical device compliance and safety for “intrusive” devices.

ObvioHealth was able to address these concerns, and more, in a recent study with Renovia, Inc. This study marked the first fully virtual clinical trial in the urogynecology space—and succeeded as a result of an innovative, decentralized trial methodology tailored to serve a bespoke study protocol.  

The results of this study, and the corresponding lessons learned, have important implications for medical device trials, both within women’s health and across therapeutic areas.
‍

Study Background

Renovia Inc. is a digital therapeutics company dedicated to improving women’s pelvic floor health. Its flagship product is an FDA-approved Class II medical device designed to treat stress urinary incontinence (SUI). This at-home pelvic digital health system (PDHS), known as the leva® device, was built on the insight that more than 75 percent of women perform pelvic floor or “Kegel” exercises (considered to be the most effective non-invasive treatment for SUI pelvic floor muscle training) incorrectly.   

leva® , marketed as “your virtual pelvic health coach,” connects to an app and illustrates the movement of patients’ pelvic floor muscles  as they exercise them to help ensure they are performing muscle contractions correctly. 

In this clinical trial, Renovia sought to evaluate the efficacy for the treatment of women with stress and mixed urinary incontinence when compared to the current standard of care (pelvic floor muscle therapy).

Initially, Renovia planned to lead a 15-site, 8-week randomized study among 350 women in the United States, in partnership with several academic medical centers. However, the onset of the COVID-19 pandemic disrupted this plan. During this uncertain period, many hospital research centers were closed, and many women in the study population were unwilling or unable to travel, so they were unlikely to attend on-site study appointments.
‍

Considerations Involved in a Decentralized Clinical Trial

Amid these concerns, Renovia needed to find a way to conduct a study and allow for full participation from patients’ homes. As Renovia began exploring the idea of a fully decentralized trial (DCT), the team posed several questions about the model.

Recruitment

Could the team achieve its stringent inclusion and exclusion criteria and recruit high-quality patients using a virtual recruitment process? Given this different recruitment approach, how many women would need to be enrolled to power the study to completion? 

eConsent

Would the participants understand their responsibilities? If they had questions, would they be able to speak with a study team member?  

Training and Data Quality

Could the study team virtually train participants to use an app for data capture while also training participants in the treatment arm to use the leva® app? Would that patient-submitted data meet quality standards? How could they ensure parity across test and control cells? 

Patient Engagement

Would older women be able to report outcomes virtually via smartphone? Could participants remain engaged and compliant without the in-person connection of site study coordinators?  

Technology

Would the DCT model be acceptable for the study’s principal investigators, who were grounded in clinical practice and had strong academic and institutional reputations? How would the team protect patient privacy while addressing any technology issues that might arise during the study?  

Safety

Would the study team be able to identify and address adverse events quickly and effectively?  

With these concerns in mind, Renovia looked for an experienced DCT partner whom they could trust to transparently and constructively address each challenge. They turned to ObvioHealth, a Virtual Research Organization (VRO) specializing in DCTs. ObvioHealth offers a range of standard CRO-related services, and its virtual site team, known as COACH (Clinical Operations And Coordination Hub), ensures direct participant support.

‍

Addressing Cohort Challenges Within a DCT Model

In addition to Renovia’s questions about the DCT model, the study population itself posed obstacles to recruitment, engagement, and compliance. Women experience a unique set of female-specific health conditions, such as incontinence related to a pelvic floor weakened by childbirth.  

These intimate topics are often perceived as “taboo” and can be uncomfortable for patients to discuss publicly in a clinic. These women often don't want to self-identify as incontinent but might answer "yes" during the recruitment process when asked if they wear pads in case of urine leakage.

Lifestyle factors among women also impact recruitment and engagement. Women of child-bearing age are likely to lead busy lives with a long list of professional and family responsibilities, which can make study participation difficult. 

While these factors typically pose significant obstacles for traditional, on-site trials, the DCT study design alleviated many of those challenges by bringing the study directly to patients on their smartphones. Renovia and ObvioHealth provided a discreet, comfortable environment for participants while improving convenience by removing the need to travel to the study site.
‍

Study Methodology

As a fully virtual study, the Renovia clinical trial incorporated DCT elements at every phase.

Recruitment and Enrollment

Digital and social media targeting delivered the sample cohort in a timely and cost-effective manner. Because there were no sites involved, ObvioHealth was able to recruit across the U.S., reaching underserved populations that would otherwise not have been aware of, or had access to, this type of trial. The recruitment campaign featured creative ads on social media channels including Facebook, Instagram, and Twitter. The plan tested multiple creative executions across three age brackets (mature, middle-aged, and young women) and then served up the most effective ad (the one with the highest click rate) for each demographic. This targeted approach resulted in recruitment costs equal to 1/10 of those from a preceding traditionally recruited trial. 

After clicking the ad, viewers arrived at a landing page where they could learn more and indicate their interest in the study. Participants enrolled via electronic informed consent (eIC) using the ObvioHealth app to complete the process.

Onboarding and Training

After the screening process, participants received system-programmed alerts through the app, which notified them of successful enrollment. The team deployed automated alerts throughout the trial to remind participants of study tasks and significant milestones. 

The study’s participant groups included: 

  • An active control group that performed pelvic floor muscle training (PFMT), more commonly known as Kegel exercises, the current standard of care. They received instructional materials, including a video and explanatory placard. 
  • The treatment arm that performed the Kegels with assistance from the leva® device. After onboarding with the leva® app, they received an instructional video and a two-sided placard developed by the American UroGynecology Society’s Voices for Pelvic Floor Disorders.  

Clinical research assistants at partner research centers spoke with participants in both arms to answer questions about how to do the exercises. 

Data Capture

This study incorporated electronic patient-reported outcomes (ePRO), which participants submitted via an app downloaded onto their mobile phones. The app was easy for participants to use and allowed for real-time data capture.

  • Bladder diary: With the click of a button, participants recorded when and how much they drank each day. 
  • Validated questionnaires: Patients answered in-app surveys at four and eight weeks to assess changes in health outcomes. These questionnaires asked participants about:
    - Difficulty emptying their bladder 
    -     How often they urinated and felt urgency to urinate
    - Their frequency of, and feelings about, bladder leakage
    -Any pelvic organ prolapse or bowel symptoms
  • leva® app usage data: Renovia directly captured leva® usage data, allowing the team to identify any technical issues
Data Monitoring

ObvioHealth’s virtual site team regularly monitored reporting adherence, and adverse events uploaded instantaneously to the platform from the app. The team was able to see these data points visualized on live platform dashboards. Adverse events were elevated first to the virtual study PI and, where relevant, to clinical experts at Massachusetts General Hospital. DCT studies support participant safety by collecting data in a nearly “real-time” environment, rather than waiting for clinic visits in a traditional site-based study.  

Participant Engagement

As the leva® trial was designed to be fully virtual, no office visits were required for participation. But, patients did speak regularly with the virtual site (COACH) team who were highly responsive via chat and email for any questions or concerns. Communications typically involved questions about how to use the app, how to finish the consent process, and how to resolve technology challenges. In addition to proactive outreach, COACH team members reached out directly to participants when they saw compliance lagging.  

During daily internal meetings, the COACH team, the clinical sites, and Renovia joined forces to resolve technology issues in real time, reviewing participant data to assess and correct device performance issues (e.g., sensor malfunctions or battery outages). The team also maintained a “smart sheet” to communicate and troubleshoot problems.
  

Study Results

This inaugural DCT study surpassed Renovia’s expectations on multiple levels, breaking new ground as the first fully virtual trial in urogynecology:

  • Recruitment of 350 participants was completed in 14 weeks. Based on 6,000 responses, the campaign yielded a cost per enrolled participant of just $67, compared with typical at-site enrollment costs of $600 to $2,000 per person.
  • The sample was also more diverse than is typical: 20% of participants were Black, Native American, or Hispanic. 
  • The study achieved an 89% retention rate and a 93.5% ePRO compliance rate. ObvioHealth was able to identify clear user segments. Those who used the device least often tended to overreport the most, but reporting improved over time as a result of regular follow up from the COACH team. 
  • Notably, older participants had a higher retention rate than their younger counterparts, relieving the sponsor’s concerns that age might impact technology adoption or usage.
  • 22% of the study cohort was aged 65 or older; the mean age was 51.2 years, and the oldest patient was 82.  
  • Only 8 people withdrew from the study after baseline.
Outcomes

Renovia achieved statistically significant results, demonstrating the efficacy of leva® over the control group for both primary outcomes. 

The primary outcome UDI-6 (Urinary Distress Inventory) was statistically significant between all timepoints. Although both groups improved, the test group improved significantly more at four weeks and even further at eight.   

The secondary outcome of Perceived Improvement showed that those using leva® had significantly less urinary distress than Kegel participants. By four weeks, there were more leva® subjects (20%) than Kegel subjects (10%) who felt “much better” or “very much better.” This improved at week eight, when 44% of leva® participants felt they were “much better” or “very much better” than the baseline, compared to 29% of Kegel participants.  

“We knew we needed to make the study easy for our patients. ObvioHealth’s virtual site delivered the support we needed for our patients, and their clinical science team provided expertise without the rigidity of a large CRO.” 
— Robin Sutherland, VP of Clinical Operations, Renovia, Inc.

‍

Lessons Learned: Opportunities for Improvement 

While the Renovia study was a success overall, the study nonetheless yielded several opportunities for improvement: 

In-App Readability

Vision challenges among the middle-aged population caused issues with text readability in the study app, which necessitated a change in font on mobile screens. 

Bladder Diary Technology

The women on the study were asked to record the amount of fluids they were drinking. However, the study team quickly identified the need to clarify what qualified as “a drink”—for example, a large iced coffee versus a sip of water—to help prevent variability in the data.  

Data Capture and Timezone

The ObvioHealth team originally designed the app for use in a UTC timezone but didn’t account for the local timezones of the patients. This was disrupting patient reporting and needed to be quickly corrected by the ObvioHealth developers so the study could proceed.

Need for Video Communication

The success of the virtual site team’s involvement in this trial points to an opportunity to amplify the human connection in future trials. The ability for participants to see study teams face to face via video calls could further improve engagement and compliance and has been advanced in the ObvioHealth platform pipeline.

‍

Key Contributors to Success and Best Practices for Future Studies 

The lessons drawn from this study lead to best practices sponsors should consider when designing a fully virtual or a hybrid clinical trial.

Effective eConsent sets patients up for success. It’s important in any study, including virtual studies, to ensure participants know what to expect regarding time commitments and responsibilities throughout the study. eConsent should be easy for participants to read, and virtual help should be readily available throughout the eConsent process.  

Thorough training is important for data accuracy. The Renovia team thoroughly trained participants on how to use the leva® device and how to perform PFMT, which helped avoid confusion for patients and helped power the study with accurate data. But, don’t forget to also train on ePRO to ensure data is consistent from patient to patient. This will avoid the issue that Renovia encountered with capturing the amount patients were drinking.  

Making ePRO easy for patients helps to increase compliance. Where applicable, design studies so patients can report symptoms or events, such as bathroom trips, with the click of a button. Conduct usability testing to ensure font sizes are readable and the app is intuitive for all patients.  

Ongoing support from a virtual site team keeps patients engaged throughout the study, provides daily management of participants, and helps mitigate any declines in participation. Deploy multiple channels for patient and study team communication—including video, phone, email, and text—and allow the patient to choose which method they prefer. 

Incorporate real-time data monitoring so the study team can engage directly when they see a patient start to falter with compliance. Real-time data is also important for quickly detecting potential AEs so the patient’s safety can be addressed sooner.  

‍

Conclusion 

The flexibility of ObvioHealth’s digital recruitment and enrollment strategies, proprietary technology, and experienced virtual site team resolved logistical and participant challenges in validating a digital device to address women’s stress incontinence. Successful recruitment, strong patient engagement, and high completion rates all contributed to the ultimate win: achieving statistically significant outcomes for the leva® device.   

Launching this study from a highly complex, multidimensionally challenging position has uniquely prepared ObvioHealth for success moving forward—both in women’s health trials and in medical device DCTs across therapeutic areas. With this case study as an example, clinical teams and sponsors alike can prepare for similar challenges and opportunities by acting on these lessons learned. 

White Paper

DCTs and Devices: Lessons Learned from a Breakthrough Medical Device Trial in Women’s Health

Men's/Women's Health
Genito Urinary
Download the PDF

Medical device trials are inherently challenging, particularly in women's health. But, within the context of a pandemic, the hurdles may seem insurmountable. Common obstacles can include:

The stigma associated with certain women’s health conditions.

The need to capture data throughout the day and night.

Participant concerns about medical device compliance and safety for “intrusive” devices.

ObvioHealth was able to address these concerns, and more, in a recent study with Renovia, Inc. This study marked the first fully virtual clinical trial in the urogynecology space—and succeeded as a result of an innovative, decentralized trial methodology tailored to serve a bespoke study protocol.  

The results of this study, and the corresponding lessons learned, have important implications for medical device trials, both within women’s health and across therapeutic areas.
‍

Study Background

Renovia Inc. is a digital therapeutics company dedicated to improving women’s pelvic floor health. Its flagship product is an FDA-approved Class II medical device designed to treat stress urinary incontinence (SUI). This at-home pelvic digital health system (PDHS), known as the leva® device, was built on the insight that more than 75 percent of women perform pelvic floor or “Kegel” exercises (considered to be the most effective non-invasive treatment for SUI pelvic floor muscle training) incorrectly.   

leva® , marketed as “your virtual pelvic health coach,” connects to an app and illustrates the movement of patients’ pelvic floor muscles  as they exercise them to help ensure they are performing muscle contractions correctly. 

In this clinical trial, Renovia sought to evaluate the efficacy for the treatment of women with stress and mixed urinary incontinence when compared to the current standard of care (pelvic floor muscle therapy).

Initially, Renovia planned to lead a 15-site, 8-week randomized study among 350 women in the United States, in partnership with several academic medical centers. However, the onset of the COVID-19 pandemic disrupted this plan. During this uncertain period, many hospital research centers were closed, and many women in the study population were unwilling or unable to travel, so they were unlikely to attend on-site study appointments.
‍

Considerations Involved in a Decentralized Clinical Trial

Amid these concerns, Renovia needed to find a way to conduct a study and allow for full participation from patients’ homes. As Renovia began exploring the idea of a fully decentralized trial (DCT), the team posed several questions about the model.

Recruitment

Could the team achieve its stringent inclusion and exclusion criteria and recruit high-quality patients using a virtual recruitment process? Given this different recruitment approach, how many women would need to be enrolled to power the study to completion? 

eConsent

Would the participants understand their responsibilities? If they had questions, would they be able to speak with a study team member?  

Training and Data Quality

Could the study team virtually train participants to use an app for data capture while also training participants in the treatment arm to use the leva® app? Would that patient-submitted data meet quality standards? How could they ensure parity across test and control cells? 

Patient Engagement

Would older women be able to report outcomes virtually via smartphone? Could participants remain engaged and compliant without the in-person connection of site study coordinators?  

Technology

Would the DCT model be acceptable for the study’s principal investigators, who were grounded in clinical practice and had strong academic and institutional reputations? How would the team protect patient privacy while addressing any technology issues that might arise during the study?  

Safety

Would the study team be able to identify and address adverse events quickly and effectively?  

With these concerns in mind, Renovia looked for an experienced DCT partner whom they could trust to transparently and constructively address each challenge. They turned to ObvioHealth, a Virtual Research Organization (VRO) specializing in DCTs. ObvioHealth offers a range of standard CRO-related services, and its virtual site team, known as COACH (Clinical Operations And Coordination Hub), ensures direct participant support.

‍

Addressing Cohort Challenges Within a DCT Model

In addition to Renovia’s questions about the DCT model, the study population itself posed obstacles to recruitment, engagement, and compliance. Women experience a unique set of female-specific health conditions, such as incontinence related to a pelvic floor weakened by childbirth.  

These intimate topics are often perceived as “taboo” and can be uncomfortable for patients to discuss publicly in a clinic. These women often don't want to self-identify as incontinent but might answer "yes" during the recruitment process when asked if they wear pads in case of urine leakage.

Lifestyle factors among women also impact recruitment and engagement. Women of child-bearing age are likely to lead busy lives with a long list of professional and family responsibilities, which can make study participation difficult. 

While these factors typically pose significant obstacles for traditional, on-site trials, the DCT study design alleviated many of those challenges by bringing the study directly to patients on their smartphones. Renovia and ObvioHealth provided a discreet, comfortable environment for participants while improving convenience by removing the need to travel to the study site.
‍

Study Methodology

As a fully virtual study, the Renovia clinical trial incorporated DCT elements at every phase.

Recruitment and Enrollment

Digital and social media targeting delivered the sample cohort in a timely and cost-effective manner. Because there were no sites involved, ObvioHealth was able to recruit across the U.S., reaching underserved populations that would otherwise not have been aware of, or had access to, this type of trial. The recruitment campaign featured creative ads on social media channels including Facebook, Instagram, and Twitter. The plan tested multiple creative executions across three age brackets (mature, middle-aged, and young women) and then served up the most effective ad (the one with the highest click rate) for each demographic. This targeted approach resulted in recruitment costs equal to 1/10 of those from a preceding traditionally recruited trial. 

After clicking the ad, viewers arrived at a landing page where they could learn more and indicate their interest in the study. Participants enrolled via electronic informed consent (eIC) using the ObvioHealth app to complete the process.

Onboarding and Training

After the screening process, participants received system-programmed alerts through the app, which notified them of successful enrollment. The team deployed automated alerts throughout the trial to remind participants of study tasks and significant milestones. 

The study’s participant groups included: 

  • An active control group that performed pelvic floor muscle training (PFMT), more commonly known as Kegel exercises, the current standard of care. They received instructional materials, including a video and explanatory placard. 
  • The treatment arm that performed the Kegels with assistance from the leva® device. After onboarding with the leva® app, they received an instructional video and a two-sided placard developed by the American UroGynecology Society’s Voices for Pelvic Floor Disorders.  

Clinical research assistants at partner research centers spoke with participants in both arms to answer questions about how to do the exercises. 

Data Capture

This study incorporated electronic patient-reported outcomes (ePRO), which participants submitted via an app downloaded onto their mobile phones. The app was easy for participants to use and allowed for real-time data capture.

  • Bladder diary: With the click of a button, participants recorded when and how much they drank each day. 
  • Validated questionnaires: Patients answered in-app surveys at four and eight weeks to assess changes in health outcomes. These questionnaires asked participants about:
    - Difficulty emptying their bladder 
    -     How often they urinated and felt urgency to urinate
    - Their frequency of, and feelings about, bladder leakage
    -Any pelvic organ prolapse or bowel symptoms
  • leva® app usage data: Renovia directly captured leva® usage data, allowing the team to identify any technical issues
Data Monitoring

ObvioHealth’s virtual site team regularly monitored reporting adherence, and adverse events uploaded instantaneously to the platform from the app. The team was able to see these data points visualized on live platform dashboards. Adverse events were elevated first to the virtual study PI and, where relevant, to clinical experts at Massachusetts General Hospital. DCT studies support participant safety by collecting data in a nearly “real-time” environment, rather than waiting for clinic visits in a traditional site-based study.  

Participant Engagement

As the leva® trial was designed to be fully virtual, no office visits were required for participation. But, patients did speak regularly with the virtual site (COACH) team who were highly responsive via chat and email for any questions or concerns. Communications typically involved questions about how to use the app, how to finish the consent process, and how to resolve technology challenges. In addition to proactive outreach, COACH team members reached out directly to participants when they saw compliance lagging.  

During daily internal meetings, the COACH team, the clinical sites, and Renovia joined forces to resolve technology issues in real time, reviewing participant data to assess and correct device performance issues (e.g., sensor malfunctions or battery outages). The team also maintained a “smart sheet” to communicate and troubleshoot problems.
  

Study Results

This inaugural DCT study surpassed Renovia’s expectations on multiple levels, breaking new ground as the first fully virtual trial in urogynecology:

  • Recruitment of 350 participants was completed in 14 weeks. Based on 6,000 responses, the campaign yielded a cost per enrolled participant of just $67, compared with typical at-site enrollment costs of $600 to $2,000 per person.
  • The sample was also more diverse than is typical: 20% of participants were Black, Native American, or Hispanic. 
  • The study achieved an 89% retention rate and a 93.5% ePRO compliance rate. ObvioHealth was able to identify clear user segments. Those who used the device least often tended to overreport the most, but reporting improved over time as a result of regular follow up from the COACH team. 
  • Notably, older participants had a higher retention rate than their younger counterparts, relieving the sponsor’s concerns that age might impact technology adoption or usage.
  • 22% of the study cohort was aged 65 or older; the mean age was 51.2 years, and the oldest patient was 82.  
  • Only 8 people withdrew from the study after baseline.
Outcomes

Renovia achieved statistically significant results, demonstrating the efficacy of leva® over the control group for both primary outcomes. 

The primary outcome UDI-6 (Urinary Distress Inventory) was statistically significant between all timepoints. Although both groups improved, the test group improved significantly more at four weeks and even further at eight.   

The secondary outcome of Perceived Improvement showed that those using leva® had significantly less urinary distress than Kegel participants. By four weeks, there were more leva® subjects (20%) than Kegel subjects (10%) who felt “much better” or “very much better.” This improved at week eight, when 44% of leva® participants felt they were “much better” or “very much better” than the baseline, compared to 29% of Kegel participants.  

“We knew we needed to make the study easy for our patients. ObvioHealth’s virtual site delivered the support we needed for our patients, and their clinical science team provided expertise without the rigidity of a large CRO.” 
— Robin Sutherland, VP of Clinical Operations, Renovia, Inc.

‍

Lessons Learned: Opportunities for Improvement 

While the Renovia study was a success overall, the study nonetheless yielded several opportunities for improvement: 

In-App Readability

Vision challenges among the middle-aged population caused issues with text readability in the study app, which necessitated a change in font on mobile screens. 

Bladder Diary Technology

The women on the study were asked to record the amount of fluids they were drinking. However, the study team quickly identified the need to clarify what qualified as “a drink”—for example, a large iced coffee versus a sip of water—to help prevent variability in the data.  

Data Capture and Timezone

The ObvioHealth team originally designed the app for use in a UTC timezone but didn’t account for the local timezones of the patients. This was disrupting patient reporting and needed to be quickly corrected by the ObvioHealth developers so the study could proceed.

Need for Video Communication

The success of the virtual site team’s involvement in this trial points to an opportunity to amplify the human connection in future trials. The ability for participants to see study teams face to face via video calls could further improve engagement and compliance and has been advanced in the ObvioHealth platform pipeline.

‍

Key Contributors to Success and Best Practices for Future Studies 

The lessons drawn from this study lead to best practices sponsors should consider when designing a fully virtual or a hybrid clinical trial.

Effective eConsent sets patients up for success. It’s important in any study, including virtual studies, to ensure participants know what to expect regarding time commitments and responsibilities throughout the study. eConsent should be easy for participants to read, and virtual help should be readily available throughout the eConsent process.  

Thorough training is important for data accuracy. The Renovia team thoroughly trained participants on how to use the leva® device and how to perform PFMT, which helped avoid confusion for patients and helped power the study with accurate data. But, don’t forget to also train on ePRO to ensure data is consistent from patient to patient. This will avoid the issue that Renovia encountered with capturing the amount patients were drinking.  

Making ePRO easy for patients helps to increase compliance. Where applicable, design studies so patients can report symptoms or events, such as bathroom trips, with the click of a button. Conduct usability testing to ensure font sizes are readable and the app is intuitive for all patients.  

Ongoing support from a virtual site team keeps patients engaged throughout the study, provides daily management of participants, and helps mitigate any declines in participation. Deploy multiple channels for patient and study team communication—including video, phone, email, and text—and allow the patient to choose which method they prefer. 

Incorporate real-time data monitoring so the study team can engage directly when they see a patient start to falter with compliance. Real-time data is also important for quickly detecting potential AEs so the patient’s safety can be addressed sooner.  

‍

Conclusion 

The flexibility of ObvioHealth’s digital recruitment and enrollment strategies, proprietary technology, and experienced virtual site team resolved logistical and participant challenges in validating a digital device to address women’s stress incontinence. Successful recruitment, strong patient engagement, and high completion rates all contributed to the ultimate win: achieving statistically significant outcomes for the leva® device.   

Launching this study from a highly complex, multidimensionally challenging position has uniquely prepared ObvioHealth for success moving forward—both in women’s health trials and in medical device DCTs across therapeutic areas. With this case study as an example, clinical teams and sponsors alike can prepare for similar challenges and opportunities by acting on these lessons learned. 

White Paper

DCTs and Devices: Lessons Learned from a Breakthrough Medical Device Trial in Women’s Health

Medical device trials are inherently challenging, particularly in women's health. But, within the context of a pandemic, the hurdles may seem insurmountable.

Men's/Women's Health
Genito Urinary
Download the PDF

Medical device trials are inherently challenging, particularly in women's health. But, within the context of a pandemic, the hurdles may seem insurmountable. Common obstacles can include:

The stigma associated with certain women’s health conditions.

The need to capture data throughout the day and night.

Participant concerns about medical device compliance and safety for “intrusive” devices.

ObvioHealth was able to address these concerns, and more, in a recent study with Renovia, Inc. This study marked the first fully virtual clinical trial in the urogynecology space—and succeeded as a result of an innovative, decentralized trial methodology tailored to serve a bespoke study protocol.  

The results of this study, and the corresponding lessons learned, have important implications for medical device trials, both within women’s health and across therapeutic areas.
‍

Study Background

Renovia Inc. is a digital therapeutics company dedicated to improving women’s pelvic floor health. Its flagship product is an FDA-approved Class II medical device designed to treat stress urinary incontinence (SUI). This at-home pelvic digital health system (PDHS), known as the leva® device, was built on the insight that more than 75 percent of women perform pelvic floor or “Kegel” exercises (considered to be the most effective non-invasive treatment for SUI pelvic floor muscle training) incorrectly.   

leva® , marketed as “your virtual pelvic health coach,” connects to an app and illustrates the movement of patients’ pelvic floor muscles  as they exercise them to help ensure they are performing muscle contractions correctly. 

In this clinical trial, Renovia sought to evaluate the efficacy for the treatment of women with stress and mixed urinary incontinence when compared to the current standard of care (pelvic floor muscle therapy).

Initially, Renovia planned to lead a 15-site, 8-week randomized study among 350 women in the United States, in partnership with several academic medical centers. However, the onset of the COVID-19 pandemic disrupted this plan. During this uncertain period, many hospital research centers were closed, and many women in the study population were unwilling or unable to travel, so they were unlikely to attend on-site study appointments.
‍

Considerations Involved in a Decentralized Clinical Trial

Amid these concerns, Renovia needed to find a way to conduct a study and allow for full participation from patients’ homes. As Renovia began exploring the idea of a fully decentralized trial (DCT), the team posed several questions about the model.

Recruitment

Could the team achieve its stringent inclusion and exclusion criteria and recruit high-quality patients using a virtual recruitment process? Given this different recruitment approach, how many women would need to be enrolled to power the study to completion? 

eConsent

Would the participants understand their responsibilities? If they had questions, would they be able to speak with a study team member?  

Training and Data Quality

Could the study team virtually train participants to use an app for data capture while also training participants in the treatment arm to use the leva® app? Would that patient-submitted data meet quality standards? How could they ensure parity across test and control cells? 

Patient Engagement

Would older women be able to report outcomes virtually via smartphone? Could participants remain engaged and compliant without the in-person connection of site study coordinators?  

Technology

Would the DCT model be acceptable for the study’s principal investigators, who were grounded in clinical practice and had strong academic and institutional reputations? How would the team protect patient privacy while addressing any technology issues that might arise during the study?  

Safety

Would the study team be able to identify and address adverse events quickly and effectively?  

With these concerns in mind, Renovia looked for an experienced DCT partner whom they could trust to transparently and constructively address each challenge. They turned to ObvioHealth, a Virtual Research Organization (VRO) specializing in DCTs. ObvioHealth offers a range of standard CRO-related services, and its virtual site team, known as COACH (Clinical Operations And Coordination Hub), ensures direct participant support.

‍

Addressing Cohort Challenges Within a DCT Model

In addition to Renovia’s questions about the DCT model, the study population itself posed obstacles to recruitment, engagement, and compliance. Women experience a unique set of female-specific health conditions, such as incontinence related to a pelvic floor weakened by childbirth.  

These intimate topics are often perceived as “taboo” and can be uncomfortable for patients to discuss publicly in a clinic. These women often don't want to self-identify as incontinent but might answer "yes" during the recruitment process when asked if they wear pads in case of urine leakage.

Lifestyle factors among women also impact recruitment and engagement. Women of child-bearing age are likely to lead busy lives with a long list of professional and family responsibilities, which can make study participation difficult. 

While these factors typically pose significant obstacles for traditional, on-site trials, the DCT study design alleviated many of those challenges by bringing the study directly to patients on their smartphones. Renovia and ObvioHealth provided a discreet, comfortable environment for participants while improving convenience by removing the need to travel to the study site.
‍

Study Methodology

As a fully virtual study, the Renovia clinical trial incorporated DCT elements at every phase.

Recruitment and Enrollment

Digital and social media targeting delivered the sample cohort in a timely and cost-effective manner. Because there were no sites involved, ObvioHealth was able to recruit across the U.S., reaching underserved populations that would otherwise not have been aware of, or had access to, this type of trial. The recruitment campaign featured creative ads on social media channels including Facebook, Instagram, and Twitter. The plan tested multiple creative executions across three age brackets (mature, middle-aged, and young women) and then served up the most effective ad (the one with the highest click rate) for each demographic. This targeted approach resulted in recruitment costs equal to 1/10 of those from a preceding traditionally recruited trial. 

After clicking the ad, viewers arrived at a landing page where they could learn more and indicate their interest in the study. Participants enrolled via electronic informed consent (eIC) using the ObvioHealth app to complete the process.

Onboarding and Training

After the screening process, participants received system-programmed alerts through the app, which notified them of successful enrollment. The team deployed automated alerts throughout the trial to remind participants of study tasks and significant milestones. 

The study’s participant groups included: 

  • An active control group that performed pelvic floor muscle training (PFMT), more commonly known as Kegel exercises, the current standard of care. They received instructional materials, including a video and explanatory placard. 
  • The treatment arm that performed the Kegels with assistance from the leva® device. After onboarding with the leva® app, they received an instructional video and a two-sided placard developed by the American UroGynecology Society’s Voices for Pelvic Floor Disorders.  

Clinical research assistants at partner research centers spoke with participants in both arms to answer questions about how to do the exercises. 

Data Capture

This study incorporated electronic patient-reported outcomes (ePRO), which participants submitted via an app downloaded onto their mobile phones. The app was easy for participants to use and allowed for real-time data capture.

  • Bladder diary: With the click of a button, participants recorded when and how much they drank each day. 
  • Validated questionnaires: Patients answered in-app surveys at four and eight weeks to assess changes in health outcomes. These questionnaires asked participants about:
    - Difficulty emptying their bladder 
    -     How often they urinated and felt urgency to urinate
    - Their frequency of, and feelings about, bladder leakage
    -Any pelvic organ prolapse or bowel symptoms
  • leva® app usage data: Renovia directly captured leva® usage data, allowing the team to identify any technical issues
Data Monitoring

ObvioHealth’s virtual site team regularly monitored reporting adherence, and adverse events uploaded instantaneously to the platform from the app. The team was able to see these data points visualized on live platform dashboards. Adverse events were elevated first to the virtual study PI and, where relevant, to clinical experts at Massachusetts General Hospital. DCT studies support participant safety by collecting data in a nearly “real-time” environment, rather than waiting for clinic visits in a traditional site-based study.  

Participant Engagement

As the leva® trial was designed to be fully virtual, no office visits were required for participation. But, patients did speak regularly with the virtual site (COACH) team who were highly responsive via chat and email for any questions or concerns. Communications typically involved questions about how to use the app, how to finish the consent process, and how to resolve technology challenges. In addition to proactive outreach, COACH team members reached out directly to participants when they saw compliance lagging.  

During daily internal meetings, the COACH team, the clinical sites, and Renovia joined forces to resolve technology issues in real time, reviewing participant data to assess and correct device performance issues (e.g., sensor malfunctions or battery outages). The team also maintained a “smart sheet” to communicate and troubleshoot problems.
  

Study Results

This inaugural DCT study surpassed Renovia’s expectations on multiple levels, breaking new ground as the first fully virtual trial in urogynecology:

  • Recruitment of 350 participants was completed in 14 weeks. Based on 6,000 responses, the campaign yielded a cost per enrolled participant of just $67, compared with typical at-site enrollment costs of $600 to $2,000 per person.
  • The sample was also more diverse than is typical: 20% of participants were Black, Native American, or Hispanic. 
  • The study achieved an 89% retention rate and a 93.5% ePRO compliance rate. ObvioHealth was able to identify clear user segments. Those who used the device least often tended to overreport the most, but reporting improved over time as a result of regular follow up from the COACH team. 
  • Notably, older participants had a higher retention rate than their younger counterparts, relieving the sponsor’s concerns that age might impact technology adoption or usage.
  • 22% of the study cohort was aged 65 or older; the mean age was 51.2 years, and the oldest patient was 82.  
  • Only 8 people withdrew from the study after baseline.
Outcomes

Renovia achieved statistically significant results, demonstrating the efficacy of leva® over the control group for both primary outcomes. 

The primary outcome UDI-6 (Urinary Distress Inventory) was statistically significant between all timepoints. Although both groups improved, the test group improved significantly more at four weeks and even further at eight.   

The secondary outcome of Perceived Improvement showed that those using leva® had significantly less urinary distress than Kegel participants. By four weeks, there were more leva® subjects (20%) than Kegel subjects (10%) who felt “much better” or “very much better.” This improved at week eight, when 44% of leva® participants felt they were “much better” or “very much better” than the baseline, compared to 29% of Kegel participants.  

“We knew we needed to make the study easy for our patients. ObvioHealth’s virtual site delivered the support we needed for our patients, and their clinical science team provided expertise without the rigidity of a large CRO.” 
— Robin Sutherland, VP of Clinical Operations, Renovia, Inc.

‍

Lessons Learned: Opportunities for Improvement 

While the Renovia study was a success overall, the study nonetheless yielded several opportunities for improvement: 

In-App Readability

Vision challenges among the middle-aged population caused issues with text readability in the study app, which necessitated a change in font on mobile screens. 

Bladder Diary Technology

The women on the study were asked to record the amount of fluids they were drinking. However, the study team quickly identified the need to clarify what qualified as “a drink”—for example, a large iced coffee versus a sip of water—to help prevent variability in the data.  

Data Capture and Timezone

The ObvioHealth team originally designed the app for use in a UTC timezone but didn’t account for the local timezones of the patients. This was disrupting patient reporting and needed to be quickly corrected by the ObvioHealth developers so the study could proceed.

Need for Video Communication

The success of the virtual site team’s involvement in this trial points to an opportunity to amplify the human connection in future trials. The ability for participants to see study teams face to face via video calls could further improve engagement and compliance and has been advanced in the ObvioHealth platform pipeline.

‍

Key Contributors to Success and Best Practices for Future Studies 

The lessons drawn from this study lead to best practices sponsors should consider when designing a fully virtual or a hybrid clinical trial.

Effective eConsent sets patients up for success. It’s important in any study, including virtual studies, to ensure participants know what to expect regarding time commitments and responsibilities throughout the study. eConsent should be easy for participants to read, and virtual help should be readily available throughout the eConsent process.  

Thorough training is important for data accuracy. The Renovia team thoroughly trained participants on how to use the leva® device and how to perform PFMT, which helped avoid confusion for patients and helped power the study with accurate data. But, don’t forget to also train on ePRO to ensure data is consistent from patient to patient. This will avoid the issue that Renovia encountered with capturing the amount patients were drinking.  

Making ePRO easy for patients helps to increase compliance. Where applicable, design studies so patients can report symptoms or events, such as bathroom trips, with the click of a button. Conduct usability testing to ensure font sizes are readable and the app is intuitive for all patients.  

Ongoing support from a virtual site team keeps patients engaged throughout the study, provides daily management of participants, and helps mitigate any declines in participation. Deploy multiple channels for patient and study team communication—including video, phone, email, and text—and allow the patient to choose which method they prefer. 

Incorporate real-time data monitoring so the study team can engage directly when they see a patient start to falter with compliance. Real-time data is also important for quickly detecting potential AEs so the patient’s safety can be addressed sooner.  

‍

Conclusion 

The flexibility of ObvioHealth’s digital recruitment and enrollment strategies, proprietary technology, and experienced virtual site team resolved logistical and participant challenges in validating a digital device to address women’s stress incontinence. Successful recruitment, strong patient engagement, and high completion rates all contributed to the ultimate win: achieving statistically significant outcomes for the leva® device.   

Launching this study from a highly complex, multidimensionally challenging position has uniquely prepared ObvioHealth for success moving forward—both in women’s health trials and in medical device DCTs across therapeutic areas. With this case study as an example, clinical teams and sponsors alike can prepare for similar challenges and opportunities by acting on these lessons learned. 

White Paper

DCTs and Devices: Lessons Learned from a Breakthrough Medical Device Trial in Women’s Health

Men's/Women's Health
Genito Urinary
Download the PDF

Medical device trials are inherently challenging, particularly in women's health. But, within the context of a pandemic, the hurdles may seem insurmountable. Common obstacles can include:

The stigma associated with certain women’s health conditions.

The need to capture data throughout the day and night.

Participant concerns about medical device compliance and safety for “intrusive” devices.

ObvioHealth was able to address these concerns, and more, in a recent study with Renovia, Inc. This study marked the first fully virtual clinical trial in the urogynecology space—and succeeded as a result of an innovative, decentralized trial methodology tailored to serve a bespoke study protocol.  

The results of this study, and the corresponding lessons learned, have important implications for medical device trials, both within women’s health and across therapeutic areas.
‍

Study Background

Renovia Inc. is a digital therapeutics company dedicated to improving women’s pelvic floor health. Its flagship product is an FDA-approved Class II medical device designed to treat stress urinary incontinence (SUI). This at-home pelvic digital health system (PDHS), known as the leva® device, was built on the insight that more than 75 percent of women perform pelvic floor or “Kegel” exercises (considered to be the most effective non-invasive treatment for SUI pelvic floor muscle training) incorrectly.   

leva® , marketed as “your virtual pelvic health coach,” connects to an app and illustrates the movement of patients’ pelvic floor muscles  as they exercise them to help ensure they are performing muscle contractions correctly. 

In this clinical trial, Renovia sought to evaluate the efficacy for the treatment of women with stress and mixed urinary incontinence when compared to the current standard of care (pelvic floor muscle therapy).

Initially, Renovia planned to lead a 15-site, 8-week randomized study among 350 women in the United States, in partnership with several academic medical centers. However, the onset of the COVID-19 pandemic disrupted this plan. During this uncertain period, many hospital research centers were closed, and many women in the study population were unwilling or unable to travel, so they were unlikely to attend on-site study appointments.
‍

Considerations Involved in a Decentralized Clinical Trial

Amid these concerns, Renovia needed to find a way to conduct a study and allow for full participation from patients’ homes. As Renovia began exploring the idea of a fully decentralized trial (DCT), the team posed several questions about the model.

Recruitment

Could the team achieve its stringent inclusion and exclusion criteria and recruit high-quality patients using a virtual recruitment process? Given this different recruitment approach, how many women would need to be enrolled to power the study to completion? 

eConsent

Would the participants understand their responsibilities? If they had questions, would they be able to speak with a study team member?  

Training and Data Quality

Could the study team virtually train participants to use an app for data capture while also training participants in the treatment arm to use the leva® app? Would that patient-submitted data meet quality standards? How could they ensure parity across test and control cells? 

Patient Engagement

Would older women be able to report outcomes virtually via smartphone? Could participants remain engaged and compliant without the in-person connection of site study coordinators?  

Technology

Would the DCT model be acceptable for the study’s principal investigators, who were grounded in clinical practice and had strong academic and institutional reputations? How would the team protect patient privacy while addressing any technology issues that might arise during the study?  

Safety

Would the study team be able to identify and address adverse events quickly and effectively?  

With these concerns in mind, Renovia looked for an experienced DCT partner whom they could trust to transparently and constructively address each challenge. They turned to ObvioHealth, a Virtual Research Organization (VRO) specializing in DCTs. ObvioHealth offers a range of standard CRO-related services, and its virtual site team, known as COACH (Clinical Operations And Coordination Hub), ensures direct participant support.

‍

Addressing Cohort Challenges Within a DCT Model

In addition to Renovia’s questions about the DCT model, the study population itself posed obstacles to recruitment, engagement, and compliance. Women experience a unique set of female-specific health conditions, such as incontinence related to a pelvic floor weakened by childbirth.  

These intimate topics are often perceived as “taboo” and can be uncomfortable for patients to discuss publicly in a clinic. These women often don't want to self-identify as incontinent but might answer "yes" during the recruitment process when asked if they wear pads in case of urine leakage.

Lifestyle factors among women also impact recruitment and engagement. Women of child-bearing age are likely to lead busy lives with a long list of professional and family responsibilities, which can make study participation difficult. 

While these factors typically pose significant obstacles for traditional, on-site trials, the DCT study design alleviated many of those challenges by bringing the study directly to patients on their smartphones. Renovia and ObvioHealth provided a discreet, comfortable environment for participants while improving convenience by removing the need to travel to the study site.
‍

Study Methodology

As a fully virtual study, the Renovia clinical trial incorporated DCT elements at every phase.

Recruitment and Enrollment

Digital and social media targeting delivered the sample cohort in a timely and cost-effective manner. Because there were no sites involved, ObvioHealth was able to recruit across the U.S., reaching underserved populations that would otherwise not have been aware of, or had access to, this type of trial. The recruitment campaign featured creative ads on social media channels including Facebook, Instagram, and Twitter. The plan tested multiple creative executions across three age brackets (mature, middle-aged, and young women) and then served up the most effective ad (the one with the highest click rate) for each demographic. This targeted approach resulted in recruitment costs equal to 1/10 of those from a preceding traditionally recruited trial. 

After clicking the ad, viewers arrived at a landing page where they could learn more and indicate their interest in the study. Participants enrolled via electronic informed consent (eIC) using the ObvioHealth app to complete the process.

Onboarding and Training

After the screening process, participants received system-programmed alerts through the app, which notified them of successful enrollment. The team deployed automated alerts throughout the trial to remind participants of study tasks and significant milestones. 

The study’s participant groups included: 

  • An active control group that performed pelvic floor muscle training (PFMT), more commonly known as Kegel exercises, the current standard of care. They received instructional materials, including a video and explanatory placard. 
  • The treatment arm that performed the Kegels with assistance from the leva® device. After onboarding with the leva® app, they received an instructional video and a two-sided placard developed by the American UroGynecology Society’s Voices for Pelvic Floor Disorders.  

Clinical research assistants at partner research centers spoke with participants in both arms to answer questions about how to do the exercises. 

Data Capture

This study incorporated electronic patient-reported outcomes (ePRO), which participants submitted via an app downloaded onto their mobile phones. The app was easy for participants to use and allowed for real-time data capture.

  • Bladder diary: With the click of a button, participants recorded when and how much they drank each day. 
  • Validated questionnaires: Patients answered in-app surveys at four and eight weeks to assess changes in health outcomes. These questionnaires asked participants about:
    - Difficulty emptying their bladder 
    -     How often they urinated and felt urgency to urinate
    - Their frequency of, and feelings about, bladder leakage
    -Any pelvic organ prolapse or bowel symptoms
  • leva® app usage data: Renovia directly captured leva® usage data, allowing the team to identify any technical issues
Data Monitoring

ObvioHealth’s virtual site team regularly monitored reporting adherence, and adverse events uploaded instantaneously to the platform from the app. The team was able to see these data points visualized on live platform dashboards. Adverse events were elevated first to the virtual study PI and, where relevant, to clinical experts at Massachusetts General Hospital. DCT studies support participant safety by collecting data in a nearly “real-time” environment, rather than waiting for clinic visits in a traditional site-based study.  

Participant Engagement

As the leva® trial was designed to be fully virtual, no office visits were required for participation. But, patients did speak regularly with the virtual site (COACH) team who were highly responsive via chat and email for any questions or concerns. Communications typically involved questions about how to use the app, how to finish the consent process, and how to resolve technology challenges. In addition to proactive outreach, COACH team members reached out directly to participants when they saw compliance lagging.  

During daily internal meetings, the COACH team, the clinical sites, and Renovia joined forces to resolve technology issues in real time, reviewing participant data to assess and correct device performance issues (e.g., sensor malfunctions or battery outages). The team also maintained a “smart sheet” to communicate and troubleshoot problems.
  

Study Results

This inaugural DCT study surpassed Renovia’s expectations on multiple levels, breaking new ground as the first fully virtual trial in urogynecology:

  • Recruitment of 350 participants was completed in 14 weeks. Based on 6,000 responses, the campaign yielded a cost per enrolled participant of just $67, compared with typical at-site enrollment costs of $600 to $2,000 per person.
  • The sample was also more diverse than is typical: 20% of participants were Black, Native American, or Hispanic. 
  • The study achieved an 89% retention rate and a 93.5% ePRO compliance rate. ObvioHealth was able to identify clear user segments. Those who used the device least often tended to overreport the most, but reporting improved over time as a result of regular follow up from the COACH team. 
  • Notably, older participants had a higher retention rate than their younger counterparts, relieving the sponsor’s concerns that age might impact technology adoption or usage.
  • 22% of the study cohort was aged 65 or older; the mean age was 51.2 years, and the oldest patient was 82.  
  • Only 8 people withdrew from the study after baseline.
Outcomes

Renovia achieved statistically significant results, demonstrating the efficacy of leva® over the control group for both primary outcomes. 

The primary outcome UDI-6 (Urinary Distress Inventory) was statistically significant between all timepoints. Although both groups improved, the test group improved significantly more at four weeks and even further at eight.   

The secondary outcome of Perceived Improvement showed that those using leva® had significantly less urinary distress than Kegel participants. By four weeks, there were more leva® subjects (20%) than Kegel subjects (10%) who felt “much better” or “very much better.” This improved at week eight, when 44% of leva® participants felt they were “much better” or “very much better” than the baseline, compared to 29% of Kegel participants.  

“We knew we needed to make the study easy for our patients. ObvioHealth’s virtual site delivered the support we needed for our patients, and their clinical science team provided expertise without the rigidity of a large CRO.” 
— Robin Sutherland, VP of Clinical Operations, Renovia, Inc.

‍

Lessons Learned: Opportunities for Improvement 

While the Renovia study was a success overall, the study nonetheless yielded several opportunities for improvement: 

In-App Readability

Vision challenges among the middle-aged population caused issues with text readability in the study app, which necessitated a change in font on mobile screens. 

Bladder Diary Technology

The women on the study were asked to record the amount of fluids they were drinking. However, the study team quickly identified the need to clarify what qualified as “a drink”—for example, a large iced coffee versus a sip of water—to help prevent variability in the data.  

Data Capture and Timezone

The ObvioHealth team originally designed the app for use in a UTC timezone but didn’t account for the local timezones of the patients. This was disrupting patient reporting and needed to be quickly corrected by the ObvioHealth developers so the study could proceed.

Need for Video Communication

The success of the virtual site team’s involvement in this trial points to an opportunity to amplify the human connection in future trials. The ability for participants to see study teams face to face via video calls could further improve engagement and compliance and has been advanced in the ObvioHealth platform pipeline.

‍

Key Contributors to Success and Best Practices for Future Studies 

The lessons drawn from this study lead to best practices sponsors should consider when designing a fully virtual or a hybrid clinical trial.

Effective eConsent sets patients up for success. It’s important in any study, including virtual studies, to ensure participants know what to expect regarding time commitments and responsibilities throughout the study. eConsent should be easy for participants to read, and virtual help should be readily available throughout the eConsent process.  

Thorough training is important for data accuracy. The Renovia team thoroughly trained participants on how to use the leva® device and how to perform PFMT, which helped avoid confusion for patients and helped power the study with accurate data. But, don’t forget to also train on ePRO to ensure data is consistent from patient to patient. This will avoid the issue that Renovia encountered with capturing the amount patients were drinking.  

Making ePRO easy for patients helps to increase compliance. Where applicable, design studies so patients can report symptoms or events, such as bathroom trips, with the click of a button. Conduct usability testing to ensure font sizes are readable and the app is intuitive for all patients.  

Ongoing support from a virtual site team keeps patients engaged throughout the study, provides daily management of participants, and helps mitigate any declines in participation. Deploy multiple channels for patient and study team communication—including video, phone, email, and text—and allow the patient to choose which method they prefer. 

Incorporate real-time data monitoring so the study team can engage directly when they see a patient start to falter with compliance. Real-time data is also important for quickly detecting potential AEs so the patient’s safety can be addressed sooner.  

‍

Conclusion 

The flexibility of ObvioHealth’s digital recruitment and enrollment strategies, proprietary technology, and experienced virtual site team resolved logistical and participant challenges in validating a digital device to address women’s stress incontinence. Successful recruitment, strong patient engagement, and high completion rates all contributed to the ultimate win: achieving statistically significant outcomes for the leva® device.   

Launching this study from a highly complex, multidimensionally challenging position has uniquely prepared ObvioHealth for success moving forward—both in women’s health trials and in medical device DCTs across therapeutic areas. With this case study as an example, clinical teams and sponsors alike can prepare for similar challenges and opportunities by acting on these lessons learned. 

White Paper

DCTs and Devices: Lessons Learned from a Breakthrough Medical Device Trial in Women’s Health

Men's/Women's Health
Genito Urinary
Download the PDF

Medical device trials are inherently challenging, particularly in women's health. But, within the context of a pandemic, the hurdles may seem insurmountable. Common obstacles can include:

The stigma associated with certain women’s health conditions.

The need to capture data throughout the day and night.

Participant concerns about medical device compliance and safety for “intrusive” devices.

ObvioHealth was able to address these concerns, and more, in a recent study with Renovia, Inc. This study marked the first fully virtual clinical trial in the urogynecology space—and succeeded as a result of an innovative, decentralized trial methodology tailored to serve a bespoke study protocol.  

The results of this study, and the corresponding lessons learned, have important implications for medical device trials, both within women’s health and across therapeutic areas.
‍

Study Background

Renovia Inc. is a digital therapeutics company dedicated to improving women’s pelvic floor health. Its flagship product is an FDA-approved Class II medical device designed to treat stress urinary incontinence (SUI). This at-home pelvic digital health system (PDHS), known as the leva® device, was built on the insight that more than 75 percent of women perform pelvic floor or “Kegel” exercises (considered to be the most effective non-invasive treatment for SUI pelvic floor muscle training) incorrectly.   

leva® , marketed as “your virtual pelvic health coach,” connects to an app and illustrates the movement of patients’ pelvic floor muscles  as they exercise them to help ensure they are performing muscle contractions correctly. 

In this clinical trial, Renovia sought to evaluate the efficacy for the treatment of women with stress and mixed urinary incontinence when compared to the current standard of care (pelvic floor muscle therapy).

Initially, Renovia planned to lead a 15-site, 8-week randomized study among 350 women in the United States, in partnership with several academic medical centers. However, the onset of the COVID-19 pandemic disrupted this plan. During this uncertain period, many hospital research centers were closed, and many women in the study population were unwilling or unable to travel, so they were unlikely to attend on-site study appointments.
‍

Considerations Involved in a Decentralized Clinical Trial

Amid these concerns, Renovia needed to find a way to conduct a study and allow for full participation from patients’ homes. As Renovia began exploring the idea of a fully decentralized trial (DCT), the team posed several questions about the model.

Recruitment

Could the team achieve its stringent inclusion and exclusion criteria and recruit high-quality patients using a virtual recruitment process? Given this different recruitment approach, how many women would need to be enrolled to power the study to completion? 

eConsent

Would the participants understand their responsibilities? If they had questions, would they be able to speak with a study team member?  

Training and Data Quality

Could the study team virtually train participants to use an app for data capture while also training participants in the treatment arm to use the leva® app? Would that patient-submitted data meet quality standards? How could they ensure parity across test and control cells? 

Patient Engagement

Would older women be able to report outcomes virtually via smartphone? Could participants remain engaged and compliant without the in-person connection of site study coordinators?  

Technology

Would the DCT model be acceptable for the study’s principal investigators, who were grounded in clinical practice and had strong academic and institutional reputations? How would the team protect patient privacy while addressing any technology issues that might arise during the study?  

Safety

Would the study team be able to identify and address adverse events quickly and effectively?  

With these concerns in mind, Renovia looked for an experienced DCT partner whom they could trust to transparently and constructively address each challenge. They turned to ObvioHealth, a Virtual Research Organization (VRO) specializing in DCTs. ObvioHealth offers a range of standard CRO-related services, and its virtual site team, known as COACH (Clinical Operations And Coordination Hub), ensures direct participant support.

‍

Addressing Cohort Challenges Within a DCT Model

In addition to Renovia’s questions about the DCT model, the study population itself posed obstacles to recruitment, engagement, and compliance. Women experience a unique set of female-specific health conditions, such as incontinence related to a pelvic floor weakened by childbirth.  

These intimate topics are often perceived as “taboo” and can be uncomfortable for patients to discuss publicly in a clinic. These women often don't want to self-identify as incontinent but might answer "yes" during the recruitment process when asked if they wear pads in case of urine leakage.

Lifestyle factors among women also impact recruitment and engagement. Women of child-bearing age are likely to lead busy lives with a long list of professional and family responsibilities, which can make study participation difficult. 

While these factors typically pose significant obstacles for traditional, on-site trials, the DCT study design alleviated many of those challenges by bringing the study directly to patients on their smartphones. Renovia and ObvioHealth provided a discreet, comfortable environment for participants while improving convenience by removing the need to travel to the study site.
‍

Study Methodology

As a fully virtual study, the Renovia clinical trial incorporated DCT elements at every phase.

Recruitment and Enrollment

Digital and social media targeting delivered the sample cohort in a timely and cost-effective manner. Because there were no sites involved, ObvioHealth was able to recruit across the U.S., reaching underserved populations that would otherwise not have been aware of, or had access to, this type of trial. The recruitment campaign featured creative ads on social media channels including Facebook, Instagram, and Twitter. The plan tested multiple creative executions across three age brackets (mature, middle-aged, and young women) and then served up the most effective ad (the one with the highest click rate) for each demographic. This targeted approach resulted in recruitment costs equal to 1/10 of those from a preceding traditionally recruited trial. 

After clicking the ad, viewers arrived at a landing page where they could learn more and indicate their interest in the study. Participants enrolled via electronic informed consent (eIC) using the ObvioHealth app to complete the process.

Onboarding and Training

After the screening process, participants received system-programmed alerts through the app, which notified them of successful enrollment. The team deployed automated alerts throughout the trial to remind participants of study tasks and significant milestones. 

The study’s participant groups included: 

  • An active control group that performed pelvic floor muscle training (PFMT), more commonly known as Kegel exercises, the current standard of care. They received instructional materials, including a video and explanatory placard. 
  • The treatment arm that performed the Kegels with assistance from the leva® device. After onboarding with the leva® app, they received an instructional video and a two-sided placard developed by the American UroGynecology Society’s Voices for Pelvic Floor Disorders.  

Clinical research assistants at partner research centers spoke with participants in both arms to answer questions about how to do the exercises. 

Data Capture

This study incorporated electronic patient-reported outcomes (ePRO), which participants submitted via an app downloaded onto their mobile phones. The app was easy for participants to use and allowed for real-time data capture.

  • Bladder diary: With the click of a button, participants recorded when and how much they drank each day. 
  • Validated questionnaires: Patients answered in-app surveys at four and eight weeks to assess changes in health outcomes. These questionnaires asked participants about:
    - Difficulty emptying their bladder 
    -     How often they urinated and felt urgency to urinate
    - Their frequency of, and feelings about, bladder leakage
    -Any pelvic organ prolapse or bowel symptoms
  • leva® app usage data: Renovia directly captured leva® usage data, allowing the team to identify any technical issues
Data Monitoring

ObvioHealth’s virtual site team regularly monitored reporting adherence, and adverse events uploaded instantaneously to the platform from the app. The team was able to see these data points visualized on live platform dashboards. Adverse events were elevated first to the virtual study PI and, where relevant, to clinical experts at Massachusetts General Hospital. DCT studies support participant safety by collecting data in a nearly “real-time” environment, rather than waiting for clinic visits in a traditional site-based study.  

Participant Engagement

As the leva® trial was designed to be fully virtual, no office visits were required for participation. But, patients did speak regularly with the virtual site (COACH) team who were highly responsive via chat and email for any questions or concerns. Communications typically involved questions about how to use the app, how to finish the consent process, and how to resolve technology challenges. In addition to proactive outreach, COACH team members reached out directly to participants when they saw compliance lagging.  

During daily internal meetings, the COACH team, the clinical sites, and Renovia joined forces to resolve technology issues in real time, reviewing participant data to assess and correct device performance issues (e.g., sensor malfunctions or battery outages). The team also maintained a “smart sheet” to communicate and troubleshoot problems.
  

Study Results

This inaugural DCT study surpassed Renovia’s expectations on multiple levels, breaking new ground as the first fully virtual trial in urogynecology:

  • Recruitment of 350 participants was completed in 14 weeks. Based on 6,000 responses, the campaign yielded a cost per enrolled participant of just $67, compared with typical at-site enrollment costs of $600 to $2,000 per person.
  • The sample was also more diverse than is typical: 20% of participants were Black, Native American, or Hispanic. 
  • The study achieved an 89% retention rate and a 93.5% ePRO compliance rate. ObvioHealth was able to identify clear user segments. Those who used the device least often tended to overreport the most, but reporting improved over time as a result of regular follow up from the COACH team. 
  • Notably, older participants had a higher retention rate than their younger counterparts, relieving the sponsor’s concerns that age might impact technology adoption or usage.
  • 22% of the study cohort was aged 65 or older; the mean age was 51.2 years, and the oldest patient was 82.  
  • Only 8 people withdrew from the study after baseline.
Outcomes

Renovia achieved statistically significant results, demonstrating the efficacy of leva® over the control group for both primary outcomes. 

The primary outcome UDI-6 (Urinary Distress Inventory) was statistically significant between all timepoints. Although both groups improved, the test group improved significantly more at four weeks and even further at eight.   

The secondary outcome of Perceived Improvement showed that those using leva® had significantly less urinary distress than Kegel participants. By four weeks, there were more leva® subjects (20%) than Kegel subjects (10%) who felt “much better” or “very much better.” This improved at week eight, when 44% of leva® participants felt they were “much better” or “very much better” than the baseline, compared to 29% of Kegel participants.  

“We knew we needed to make the study easy for our patients. ObvioHealth’s virtual site delivered the support we needed for our patients, and their clinical science team provided expertise without the rigidity of a large CRO.” 
— Robin Sutherland, VP of Clinical Operations, Renovia, Inc.

‍

Lessons Learned: Opportunities for Improvement 

While the Renovia study was a success overall, the study nonetheless yielded several opportunities for improvement: 

In-App Readability

Vision challenges among the middle-aged population caused issues with text readability in the study app, which necessitated a change in font on mobile screens. 

Bladder Diary Technology

The women on the study were asked to record the amount of fluids they were drinking. However, the study team quickly identified the need to clarify what qualified as “a drink”—for example, a large iced coffee versus a sip of water—to help prevent variability in the data.  

Data Capture and Timezone

The ObvioHealth team originally designed the app for use in a UTC timezone but didn’t account for the local timezones of the patients. This was disrupting patient reporting and needed to be quickly corrected by the ObvioHealth developers so the study could proceed.

Need for Video Communication

The success of the virtual site team’s involvement in this trial points to an opportunity to amplify the human connection in future trials. The ability for participants to see study teams face to face via video calls could further improve engagement and compliance and has been advanced in the ObvioHealth platform pipeline.

‍

Key Contributors to Success and Best Practices for Future Studies 

The lessons drawn from this study lead to best practices sponsors should consider when designing a fully virtual or a hybrid clinical trial.

Effective eConsent sets patients up for success. It’s important in any study, including virtual studies, to ensure participants know what to expect regarding time commitments and responsibilities throughout the study. eConsent should be easy for participants to read, and virtual help should be readily available throughout the eConsent process.  

Thorough training is important for data accuracy. The Renovia team thoroughly trained participants on how to use the leva® device and how to perform PFMT, which helped avoid confusion for patients and helped power the study with accurate data. But, don’t forget to also train on ePRO to ensure data is consistent from patient to patient. This will avoid the issue that Renovia encountered with capturing the amount patients were drinking.  

Making ePRO easy for patients helps to increase compliance. Where applicable, design studies so patients can report symptoms or events, such as bathroom trips, with the click of a button. Conduct usability testing to ensure font sizes are readable and the app is intuitive for all patients.  

Ongoing support from a virtual site team keeps patients engaged throughout the study, provides daily management of participants, and helps mitigate any declines in participation. Deploy multiple channels for patient and study team communication—including video, phone, email, and text—and allow the patient to choose which method they prefer. 

Incorporate real-time data monitoring so the study team can engage directly when they see a patient start to falter with compliance. Real-time data is also important for quickly detecting potential AEs so the patient’s safety can be addressed sooner.  

‍

Conclusion 

The flexibility of ObvioHealth’s digital recruitment and enrollment strategies, proprietary technology, and experienced virtual site team resolved logistical and participant challenges in validating a digital device to address women’s stress incontinence. Successful recruitment, strong patient engagement, and high completion rates all contributed to the ultimate win: achieving statistically significant outcomes for the leva® device.   

Launching this study from a highly complex, multidimensionally challenging position has uniquely prepared ObvioHealth for success moving forward—both in women’s health trials and in medical device DCTs across therapeutic areas. With this case study as an example, clinical teams and sponsors alike can prepare for similar challenges and opportunities by acting on these lessons learned. 

White Paper

DCTs and Devices: Lessons Learned from a Breakthrough Medical Device Trial in Women’s Health

Medical device trials are inherently challenging, particularly in women's health. But, within the context of a pandemic, the hurdles may seem insurmountable.

Download the PDF
Men's/Women's Health
Genito Urinary

Medical device trials are inherently challenging, particularly in women's health. But, within the context of a pandemic, the hurdles may seem insurmountable. Common obstacles can include:

The stigma associated with certain women’s health conditions.

The need to capture data throughout the day and night.

Participant concerns about medical device compliance and safety for “intrusive” devices.

ObvioHealth was able to address these concerns, and more, in a recent study with Renovia, Inc. This study marked the first fully virtual clinical trial in the urogynecology space—and succeeded as a result of an innovative, decentralized trial methodology tailored to serve a bespoke study protocol.  

The results of this study, and the corresponding lessons learned, have important implications for medical device trials, both within women’s health and across therapeutic areas.
‍

Study Background

Renovia Inc. is a digital therapeutics company dedicated to improving women’s pelvic floor health. Its flagship product is an FDA-approved Class II medical device designed to treat stress urinary incontinence (SUI). This at-home pelvic digital health system (PDHS), known as the leva® device, was built on the insight that more than 75 percent of women perform pelvic floor or “Kegel” exercises (considered to be the most effective non-invasive treatment for SUI pelvic floor muscle training) incorrectly.   

leva® , marketed as “your virtual pelvic health coach,” connects to an app and illustrates the movement of patients’ pelvic floor muscles  as they exercise them to help ensure they are performing muscle contractions correctly. 

In this clinical trial, Renovia sought to evaluate the efficacy for the treatment of women with stress and mixed urinary incontinence when compared to the current standard of care (pelvic floor muscle therapy).

Initially, Renovia planned to lead a 15-site, 8-week randomized study among 350 women in the United States, in partnership with several academic medical centers. However, the onset of the COVID-19 pandemic disrupted this plan. During this uncertain period, many hospital research centers were closed, and many women in the study population were unwilling or unable to travel, so they were unlikely to attend on-site study appointments.
‍

Considerations Involved in a Decentralized Clinical Trial

Amid these concerns, Renovia needed to find a way to conduct a study and allow for full participation from patients’ homes. As Renovia began exploring the idea of a fully decentralized trial (DCT), the team posed several questions about the model.

Recruitment

Could the team achieve its stringent inclusion and exclusion criteria and recruit high-quality patients using a virtual recruitment process? Given this different recruitment approach, how many women would need to be enrolled to power the study to completion? 

eConsent

Would the participants understand their responsibilities? If they had questions, would they be able to speak with a study team member?  

Training and Data Quality

Could the study team virtually train participants to use an app for data capture while also training participants in the treatment arm to use the leva® app? Would that patient-submitted data meet quality standards? How could they ensure parity across test and control cells? 

Patient Engagement

Would older women be able to report outcomes virtually via smartphone? Could participants remain engaged and compliant without the in-person connection of site study coordinators?  

Technology

Would the DCT model be acceptable for the study’s principal investigators, who were grounded in clinical practice and had strong academic and institutional reputations? How would the team protect patient privacy while addressing any technology issues that might arise during the study?  

Safety

Would the study team be able to identify and address adverse events quickly and effectively?  

With these concerns in mind, Renovia looked for an experienced DCT partner whom they could trust to transparently and constructively address each challenge. They turned to ObvioHealth, a Virtual Research Organization (VRO) specializing in DCTs. ObvioHealth offers a range of standard CRO-related services, and its virtual site team, known as COACH (Clinical Operations And Coordination Hub), ensures direct participant support.

‍

Addressing Cohort Challenges Within a DCT Model

In addition to Renovia’s questions about the DCT model, the study population itself posed obstacles to recruitment, engagement, and compliance. Women experience a unique set of female-specific health conditions, such as incontinence related to a pelvic floor weakened by childbirth.  

These intimate topics are often perceived as “taboo” and can be uncomfortable for patients to discuss publicly in a clinic. These women often don't want to self-identify as incontinent but might answer "yes" during the recruitment process when asked if they wear pads in case of urine leakage.

Lifestyle factors among women also impact recruitment and engagement. Women of child-bearing age are likely to lead busy lives with a long list of professional and family responsibilities, which can make study participation difficult. 

While these factors typically pose significant obstacles for traditional, on-site trials, the DCT study design alleviated many of those challenges by bringing the study directly to patients on their smartphones. Renovia and ObvioHealth provided a discreet, comfortable environment for participants while improving convenience by removing the need to travel to the study site.
‍

Study Methodology

As a fully virtual study, the Renovia clinical trial incorporated DCT elements at every phase.

Recruitment and Enrollment

Digital and social media targeting delivered the sample cohort in a timely and cost-effective manner. Because there were no sites involved, ObvioHealth was able to recruit across the U.S., reaching underserved populations that would otherwise not have been aware of, or had access to, this type of trial. The recruitment campaign featured creative ads on social media channels including Facebook, Instagram, and Twitter. The plan tested multiple creative executions across three age brackets (mature, middle-aged, and young women) and then served up the most effective ad (the one with the highest click rate) for each demographic. This targeted approach resulted in recruitment costs equal to 1/10 of those from a preceding traditionally recruited trial. 

After clicking the ad, viewers arrived at a landing page where they could learn more and indicate their interest in the study. Participants enrolled via electronic informed consent (eIC) using the ObvioHealth app to complete the process.

Onboarding and Training

After the screening process, participants received system-programmed alerts through the app, which notified them of successful enrollment. The team deployed automated alerts throughout the trial to remind participants of study tasks and significant milestones. 

The study’s participant groups included: 

  • An active control group that performed pelvic floor muscle training (PFMT), more commonly known as Kegel exercises, the current standard of care. They received instructional materials, including a video and explanatory placard. 
  • The treatment arm that performed the Kegels with assistance from the leva® device. After onboarding with the leva® app, they received an instructional video and a two-sided placard developed by the American UroGynecology Society’s Voices for Pelvic Floor Disorders.  

Clinical research assistants at partner research centers spoke with participants in both arms to answer questions about how to do the exercises. 

Data Capture

This study incorporated electronic patient-reported outcomes (ePRO), which participants submitted via an app downloaded onto their mobile phones. The app was easy for participants to use and allowed for real-time data capture.

  • Bladder diary: With the click of a button, participants recorded when and how much they drank each day. 
  • Validated questionnaires: Patients answered in-app surveys at four and eight weeks to assess changes in health outcomes. These questionnaires asked participants about:
    - Difficulty emptying their bladder 
    -     How often they urinated and felt urgency to urinate
    - Their frequency of, and feelings about, bladder leakage
    -Any pelvic organ prolapse or bowel symptoms
  • leva® app usage data: Renovia directly captured leva® usage data, allowing the team to identify any technical issues
Data Monitoring

ObvioHealth’s virtual site team regularly monitored reporting adherence, and adverse events uploaded instantaneously to the platform from the app. The team was able to see these data points visualized on live platform dashboards. Adverse events were elevated first to the virtual study PI and, where relevant, to clinical experts at Massachusetts General Hospital. DCT studies support participant safety by collecting data in a nearly “real-time” environment, rather than waiting for clinic visits in a traditional site-based study.  

Participant Engagement

As the leva® trial was designed to be fully virtual, no office visits were required for participation. But, patients did speak regularly with the virtual site (COACH) team who were highly responsive via chat and email for any questions or concerns. Communications typically involved questions about how to use the app, how to finish the consent process, and how to resolve technology challenges. In addition to proactive outreach, COACH team members reached out directly to participants when they saw compliance lagging.  

During daily internal meetings, the COACH team, the clinical sites, and Renovia joined forces to resolve technology issues in real time, reviewing participant data to assess and correct device performance issues (e.g., sensor malfunctions or battery outages). The team also maintained a “smart sheet” to communicate and troubleshoot problems.
  

Study Results

This inaugural DCT study surpassed Renovia’s expectations on multiple levels, breaking new ground as the first fully virtual trial in urogynecology:

  • Recruitment of 350 participants was completed in 14 weeks. Based on 6,000 responses, the campaign yielded a cost per enrolled participant of just $67, compared with typical at-site enrollment costs of $600 to $2,000 per person.
  • The sample was also more diverse than is typical: 20% of participants were Black, Native American, or Hispanic. 
  • The study achieved an 89% retention rate and a 93.5% ePRO compliance rate. ObvioHealth was able to identify clear user segments. Those who used the device least often tended to overreport the most, but reporting improved over time as a result of regular follow up from the COACH team. 
  • Notably, older participants had a higher retention rate than their younger counterparts, relieving the sponsor’s concerns that age might impact technology adoption or usage.
  • 22% of the study cohort was aged 65 or older; the mean age was 51.2 years, and the oldest patient was 82.  
  • Only 8 people withdrew from the study after baseline.
Outcomes

Renovia achieved statistically significant results, demonstrating the efficacy of leva® over the control group for both primary outcomes. 

The primary outcome UDI-6 (Urinary Distress Inventory) was statistically significant between all timepoints. Although both groups improved, the test group improved significantly more at four weeks and even further at eight.   

The secondary outcome of Perceived Improvement showed that those using leva® had significantly less urinary distress than Kegel participants. By four weeks, there were more leva® subjects (20%) than Kegel subjects (10%) who felt “much better” or “very much better.” This improved at week eight, when 44% of leva® participants felt they were “much better” or “very much better” than the baseline, compared to 29% of Kegel participants.  

“We knew we needed to make the study easy for our patients. ObvioHealth’s virtual site delivered the support we needed for our patients, and their clinical science team provided expertise without the rigidity of a large CRO.” 
— Robin Sutherland, VP of Clinical Operations, Renovia, Inc.

‍

Lessons Learned: Opportunities for Improvement 

While the Renovia study was a success overall, the study nonetheless yielded several opportunities for improvement: 

In-App Readability

Vision challenges among the middle-aged population caused issues with text readability in the study app, which necessitated a change in font on mobile screens. 

Bladder Diary Technology

The women on the study were asked to record the amount of fluids they were drinking. However, the study team quickly identified the need to clarify what qualified as “a drink”—for example, a large iced coffee versus a sip of water—to help prevent variability in the data.  

Data Capture and Timezone

The ObvioHealth team originally designed the app for use in a UTC timezone but didn’t account for the local timezones of the patients. This was disrupting patient reporting and needed to be quickly corrected by the ObvioHealth developers so the study could proceed.

Need for Video Communication

The success of the virtual site team’s involvement in this trial points to an opportunity to amplify the human connection in future trials. The ability for participants to see study teams face to face via video calls could further improve engagement and compliance and has been advanced in the ObvioHealth platform pipeline.

‍

Key Contributors to Success and Best Practices for Future Studies 

The lessons drawn from this study lead to best practices sponsors should consider when designing a fully virtual or a hybrid clinical trial.

Effective eConsent sets patients up for success. It’s important in any study, including virtual studies, to ensure participants know what to expect regarding time commitments and responsibilities throughout the study. eConsent should be easy for participants to read, and virtual help should be readily available throughout the eConsent process.  

Thorough training is important for data accuracy. The Renovia team thoroughly trained participants on how to use the leva® device and how to perform PFMT, which helped avoid confusion for patients and helped power the study with accurate data. But, don’t forget to also train on ePRO to ensure data is consistent from patient to patient. This will avoid the issue that Renovia encountered with capturing the amount patients were drinking.  

Making ePRO easy for patients helps to increase compliance. Where applicable, design studies so patients can report symptoms or events, such as bathroom trips, with the click of a button. Conduct usability testing to ensure font sizes are readable and the app is intuitive for all patients.  

Ongoing support from a virtual site team keeps patients engaged throughout the study, provides daily management of participants, and helps mitigate any declines in participation. Deploy multiple channels for patient and study team communication—including video, phone, email, and text—and allow the patient to choose which method they prefer. 

Incorporate real-time data monitoring so the study team can engage directly when they see a patient start to falter with compliance. Real-time data is also important for quickly detecting potential AEs so the patient’s safety can be addressed sooner.  

‍

Conclusion 

The flexibility of ObvioHealth’s digital recruitment and enrollment strategies, proprietary technology, and experienced virtual site team resolved logistical and participant challenges in validating a digital device to address women’s stress incontinence. Successful recruitment, strong patient engagement, and high completion rates all contributed to the ultimate win: achieving statistically significant outcomes for the leva® device.   

Launching this study from a highly complex, multidimensionally challenging position has uniquely prepared ObvioHealth for success moving forward—both in women’s health trials and in medical device DCTs across therapeutic areas. With this case study as an example, clinical teams and sponsors alike can prepare for similar challenges and opportunities by acting on these lessons learned. 

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White Paper

DCTs and Devices: Lessons Learned from a Breakthrough Medical Device Trial in Women’s Health

Medical device trials are inherently challenging, particularly in women's health. But, within the context of a pandemic, the hurdles may seem insurmountable.

Men's/Women's Health
Genito Urinary
Download the PDF

Medical device trials are inherently challenging, particularly in women's health. But, within the context of a pandemic, the hurdles may seem insurmountable. Common obstacles can include:

The stigma associated with certain women’s health conditions.

The need to capture data throughout the day and night.

Participant concerns about medical device compliance and safety for “intrusive” devices.

ObvioHealth was able to address these concerns, and more, in a recent study with Renovia, Inc. This study marked the first fully virtual clinical trial in the urogynecology space—and succeeded as a result of an innovative, decentralized trial methodology tailored to serve a bespoke study protocol.  

The results of this study, and the corresponding lessons learned, have important implications for medical device trials, both within women’s health and across therapeutic areas.
‍

Study Background

Renovia Inc. is a digital therapeutics company dedicated to improving women’s pelvic floor health. Its flagship product is an FDA-approved Class II medical device designed to treat stress urinary incontinence (SUI). This at-home pelvic digital health system (PDHS), known as the leva® device, was built on the insight that more than 75 percent of women perform pelvic floor or “Kegel” exercises (considered to be the most effective non-invasive treatment for SUI pelvic floor muscle training) incorrectly.   

leva® , marketed as “your virtual pelvic health coach,” connects to an app and illustrates the movement of patients’ pelvic floor muscles  as they exercise them to help ensure they are performing muscle contractions correctly. 

In this clinical trial, Renovia sought to evaluate the efficacy for the treatment of women with stress and mixed urinary incontinence when compared to the current standard of care (pelvic floor muscle therapy).

Initially, Renovia planned to lead a 15-site, 8-week randomized study among 350 women in the United States, in partnership with several academic medical centers. However, the onset of the COVID-19 pandemic disrupted this plan. During this uncertain period, many hospital research centers were closed, and many women in the study population were unwilling or unable to travel, so they were unlikely to attend on-site study appointments.
‍

Considerations Involved in a Decentralized Clinical Trial

Amid these concerns, Renovia needed to find a way to conduct a study and allow for full participation from patients’ homes. As Renovia began exploring the idea of a fully decentralized trial (DCT), the team posed several questions about the model.

Recruitment

Could the team achieve its stringent inclusion and exclusion criteria and recruit high-quality patients using a virtual recruitment process? Given this different recruitment approach, how many women would need to be enrolled to power the study to completion? 

eConsent

Would the participants understand their responsibilities? If they had questions, would they be able to speak with a study team member?  

Training and Data Quality

Could the study team virtually train participants to use an app for data capture while also training participants in the treatment arm to use the leva® app? Would that patient-submitted data meet quality standards? How could they ensure parity across test and control cells? 

Patient Engagement

Would older women be able to report outcomes virtually via smartphone? Could participants remain engaged and compliant without the in-person connection of site study coordinators?  

Technology

Would the DCT model be acceptable for the study’s principal investigators, who were grounded in clinical practice and had strong academic and institutional reputations? How would the team protect patient privacy while addressing any technology issues that might arise during the study?  

Safety

Would the study team be able to identify and address adverse events quickly and effectively?  

With these concerns in mind, Renovia looked for an experienced DCT partner whom they could trust to transparently and constructively address each challenge. They turned to ObvioHealth, a Virtual Research Organization (VRO) specializing in DCTs. ObvioHealth offers a range of standard CRO-related services, and its virtual site team, known as COACH (Clinical Operations And Coordination Hub), ensures direct participant support.

‍

Addressing Cohort Challenges Within a DCT Model

In addition to Renovia’s questions about the DCT model, the study population itself posed obstacles to recruitment, engagement, and compliance. Women experience a unique set of female-specific health conditions, such as incontinence related to a pelvic floor weakened by childbirth.  

These intimate topics are often perceived as “taboo” and can be uncomfortable for patients to discuss publicly in a clinic. These women often don't want to self-identify as incontinent but might answer "yes" during the recruitment process when asked if they wear pads in case of urine leakage.

Lifestyle factors among women also impact recruitment and engagement. Women of child-bearing age are likely to lead busy lives with a long list of professional and family responsibilities, which can make study participation difficult. 

While these factors typically pose significant obstacles for traditional, on-site trials, the DCT study design alleviated many of those challenges by bringing the study directly to patients on their smartphones. Renovia and ObvioHealth provided a discreet, comfortable environment for participants while improving convenience by removing the need to travel to the study site.
‍

Study Methodology

As a fully virtual study, the Renovia clinical trial incorporated DCT elements at every phase.

Recruitment and Enrollment

Digital and social media targeting delivered the sample cohort in a timely and cost-effective manner. Because there were no sites involved, ObvioHealth was able to recruit across the U.S., reaching underserved populations that would otherwise not have been aware of, or had access to, this type of trial. The recruitment campaign featured creative ads on social media channels including Facebook, Instagram, and Twitter. The plan tested multiple creative executions across three age brackets (mature, middle-aged, and young women) and then served up the most effective ad (the one with the highest click rate) for each demographic. This targeted approach resulted in recruitment costs equal to 1/10 of those from a preceding traditionally recruited trial. 

After clicking the ad, viewers arrived at a landing page where they could learn more and indicate their interest in the study. Participants enrolled via electronic informed consent (eIC) using the ObvioHealth app to complete the process.

Onboarding and Training

After the screening process, participants received system-programmed alerts through the app, which notified them of successful enrollment. The team deployed automated alerts throughout the trial to remind participants of study tasks and significant milestones. 

The study’s participant groups included: 

  • An active control group that performed pelvic floor muscle training (PFMT), more commonly known as Kegel exercises, the current standard of care. They received instructional materials, including a video and explanatory placard. 
  • The treatment arm that performed the Kegels with assistance from the leva® device. After onboarding with the leva® app, they received an instructional video and a two-sided placard developed by the American UroGynecology Society’s Voices for Pelvic Floor Disorders.  

Clinical research assistants at partner research centers spoke with participants in both arms to answer questions about how to do the exercises. 

Data Capture

This study incorporated electronic patient-reported outcomes (ePRO), which participants submitted via an app downloaded onto their mobile phones. The app was easy for participants to use and allowed for real-time data capture.

  • Bladder diary: With the click of a button, participants recorded when and how much they drank each day. 
  • Validated questionnaires: Patients answered in-app surveys at four and eight weeks to assess changes in health outcomes. These questionnaires asked participants about:
    - Difficulty emptying their bladder 
    -     How often they urinated and felt urgency to urinate
    - Their frequency of, and feelings about, bladder leakage
    -Any pelvic organ prolapse or bowel symptoms
  • leva® app usage data: Renovia directly captured leva® usage data, allowing the team to identify any technical issues
Data Monitoring

ObvioHealth’s virtual site team regularly monitored reporting adherence, and adverse events uploaded instantaneously to the platform from the app. The team was able to see these data points visualized on live platform dashboards. Adverse events were elevated first to the virtual study PI and, where relevant, to clinical experts at Massachusetts General Hospital. DCT studies support participant safety by collecting data in a nearly “real-time” environment, rather than waiting for clinic visits in a traditional site-based study.  

Participant Engagement

As the leva® trial was designed to be fully virtual, no office visits were required for participation. But, patients did speak regularly with the virtual site (COACH) team who were highly responsive via chat and email for any questions or concerns. Communications typically involved questions about how to use the app, how to finish the consent process, and how to resolve technology challenges. In addition to proactive outreach, COACH team members reached out directly to participants when they saw compliance lagging.  

During daily internal meetings, the COACH team, the clinical sites, and Renovia joined forces to resolve technology issues in real time, reviewing participant data to assess and correct device performance issues (e.g., sensor malfunctions or battery outages). The team also maintained a “smart sheet” to communicate and troubleshoot problems.
  

Study Results

This inaugural DCT study surpassed Renovia’s expectations on multiple levels, breaking new ground as the first fully virtual trial in urogynecology:

  • Recruitment of 350 participants was completed in 14 weeks. Based on 6,000 responses, the campaign yielded a cost per enrolled participant of just $67, compared with typical at-site enrollment costs of $600 to $2,000 per person.
  • The sample was also more diverse than is typical: 20% of participants were Black, Native American, or Hispanic. 
  • The study achieved an 89% retention rate and a 93.5% ePRO compliance rate. ObvioHealth was able to identify clear user segments. Those who used the device least often tended to overreport the most, but reporting improved over time as a result of regular follow up from the COACH team. 
  • Notably, older participants had a higher retention rate than their younger counterparts, relieving the sponsor’s concerns that age might impact technology adoption or usage.
  • 22% of the study cohort was aged 65 or older; the mean age was 51.2 years, and the oldest patient was 82.  
  • Only 8 people withdrew from the study after baseline.
Outcomes

Renovia achieved statistically significant results, demonstrating the efficacy of leva® over the control group for both primary outcomes. 

The primary outcome UDI-6 (Urinary Distress Inventory) was statistically significant between all timepoints. Although both groups improved, the test group improved significantly more at four weeks and even further at eight.   

The secondary outcome of Perceived Improvement showed that those using leva® had significantly less urinary distress than Kegel participants. By four weeks, there were more leva® subjects (20%) than Kegel subjects (10%) who felt “much better” or “very much better.” This improved at week eight, when 44% of leva® participants felt they were “much better” or “very much better” than the baseline, compared to 29% of Kegel participants.  

“We knew we needed to make the study easy for our patients. ObvioHealth’s virtual site delivered the support we needed for our patients, and their clinical science team provided expertise without the rigidity of a large CRO.” 
— Robin Sutherland, VP of Clinical Operations, Renovia, Inc.

‍

Lessons Learned: Opportunities for Improvement 

While the Renovia study was a success overall, the study nonetheless yielded several opportunities for improvement: 

In-App Readability

Vision challenges among the middle-aged population caused issues with text readability in the study app, which necessitated a change in font on mobile screens. 

Bladder Diary Technology

The women on the study were asked to record the amount of fluids they were drinking. However, the study team quickly identified the need to clarify what qualified as “a drink”—for example, a large iced coffee versus a sip of water—to help prevent variability in the data.  

Data Capture and Timezone

The ObvioHealth team originally designed the app for use in a UTC timezone but didn’t account for the local timezones of the patients. This was disrupting patient reporting and needed to be quickly corrected by the ObvioHealth developers so the study could proceed.

Need for Video Communication

The success of the virtual site team’s involvement in this trial points to an opportunity to amplify the human connection in future trials. The ability for participants to see study teams face to face via video calls could further improve engagement and compliance and has been advanced in the ObvioHealth platform pipeline.

‍

Key Contributors to Success and Best Practices for Future Studies 

The lessons drawn from this study lead to best practices sponsors should consider when designing a fully virtual or a hybrid clinical trial.

Effective eConsent sets patients up for success. It’s important in any study, including virtual studies, to ensure participants know what to expect regarding time commitments and responsibilities throughout the study. eConsent should be easy for participants to read, and virtual help should be readily available throughout the eConsent process.  

Thorough training is important for data accuracy. The Renovia team thoroughly trained participants on how to use the leva® device and how to perform PFMT, which helped avoid confusion for patients and helped power the study with accurate data. But, don’t forget to also train on ePRO to ensure data is consistent from patient to patient. This will avoid the issue that Renovia encountered with capturing the amount patients were drinking.  

Making ePRO easy for patients helps to increase compliance. Where applicable, design studies so patients can report symptoms or events, such as bathroom trips, with the click of a button. Conduct usability testing to ensure font sizes are readable and the app is intuitive for all patients.  

Ongoing support from a virtual site team keeps patients engaged throughout the study, provides daily management of participants, and helps mitigate any declines in participation. Deploy multiple channels for patient and study team communication—including video, phone, email, and text—and allow the patient to choose which method they prefer. 

Incorporate real-time data monitoring so the study team can engage directly when they see a patient start to falter with compliance. Real-time data is also important for quickly detecting potential AEs so the patient’s safety can be addressed sooner.  

‍

Conclusion 

The flexibility of ObvioHealth’s digital recruitment and enrollment strategies, proprietary technology, and experienced virtual site team resolved logistical and participant challenges in validating a digital device to address women’s stress incontinence. Successful recruitment, strong patient engagement, and high completion rates all contributed to the ultimate win: achieving statistically significant outcomes for the leva® device.   

Launching this study from a highly complex, multidimensionally challenging position has uniquely prepared ObvioHealth for success moving forward—both in women’s health trials and in medical device DCTs across therapeutic areas. With this case study as an example, clinical teams and sponsors alike can prepare for similar challenges and opportunities by acting on these lessons learned. 

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